Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique

Insomnia Clinical Trial

Official title:

Improving the Mental Health & Well-Being of Healthcare Providers During the COVID-19 Pandemic: A Parallel Population Study Investigating the Reduction of Burnout and Enhancement of Well-Being Through the Transcendental Meditation Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239429
• Other study ID #: CCCR 01-2020
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2023
• Source: The Center for Clinical and Cosmetic Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The level of stress-related disorders experienced by Healthcare Providers (HCPs) has increased due to the recent COVID-19 Pandemic, impacting patient care and provider shortages. This trial aims to evaluate the use of the Transcendental Meditation Technique in improving burnout and wellbeing of HCPs over a 3-month trial period.

A total of 130 HCPs will be recruited from participating Miami hospitals, with 65 HCPs receiving training in the use of the Transcendental Meditation Technique. The remaining participants will be part of a matched control group and will not receive any training. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months.

Description:

This parallel population study aims to optimize and evaluate Healthcare Provider (HCP) wellness and performance through an evidence-based stress reduction program, Transcendental Meditation.

Transcendental Meditation (TM) has been found to be effective in reducing adverse mental health outcomes, including burnout, emotional exhaustion, depression, anxiety, insomnia, and trauma symptom severity. It is a mind-body program that allows the practitioner to experience progressively quieter, less excited states of mental activity.

For this trail, 65 HCPs affiliated with three participating Miami hospitals (Baptist Health South Florida Hospital, Mercy Miami Hospital and Encompass Health Rehabilitation Hospital of Miami) will receive instructions in the Transcendental Meditation Technique. A control group of similar numbers of HCPs will be recruited to match, to the best extent possible, for gender, age, type of HCP (doctor, nurse, etc.), and work schedule (e.g., days, nights, etc.). The control group participants will not receive Transcendental Meditation Technique training and will continue with their usual lifestyle.

The total duration of the study period will be 3 months. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months' posttest, with change in burnout, insomnia, symptom, and well-being, as measured by the corresponding indexes as the primary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Fulltime healthcare providers, medical doctors, physician assistants, nurses or other HCPs involved in active patient care or administration of patient care (Hospital Administration).

2. 18 years or older.

3. Have treated COVID-19 patients or working at locations where COVID-19 patients are being treated.

4. Willing and able to complete both baseline and post-testing.

5. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment.

6. In the non-control group, willing and able to dedicate the time to learning the Transcendental Meditation technique and practice it twice daily for approximately 20 minutes.

Exclusion Criteria:

1. Already instructed in the Transcendental Meditation technique.

2. Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months.

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Well Being

Intervention

Behavioral:
• Transcendental Meditation Technique
Participants receive one-on-one training on how to use Transcendental Meditation technique which is then practiced twice daily for approximately 20 minutes.

Locations

Country	Name	City	State
United States	The Center for Clinical and Cosmetic Research	Aventura	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Clinical and Cosmetic Research	David Lynch Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maslach Burnout Inventory- Human Services Survey (MBI-HSS) Score from Baseline	The Maslach Burnout Inventory- Human Services Survey (MBI-HSS) for Medical Personnel is used to measure participant burnout.; The scale is a 22-item inventory with a seven-point response scale of 0-6 (0=never; 6= Every day).	Baseline, 2 weeks, 1 month, and 3 months
Primary	Change from Baseline in Insomnia Severity Index (ISI) Score	The Insomnia Severity Index (ISI) scale contains 7 sleep-related questions to measure severity of sleep problems.; A total score is calculated to interpret the participants level of insomnia, with a total score of 0-7 indicating no clinically significant insomnia and a score of 22-18 indicative of severe Clinical Insomnia.	Baseline, 2 weeks, 1 month, and 3 months
Primary	Change from Baseline in Brief Symptom Inventory 18 (BSI 18) Score	The Brief Symptom Inventory 18 (BSI 18) is a 5-point rating scale used to gather patient-reported data to measure psychological distress and psychiatric disorders.	Baseline, 2 weeks, 1 month, and 3 months
Primary	Change in Warwick-Edinburgh Mental Well Being Scale (WEMWBS) Score from Baseline	The Warwick-Edinburgh Mental Well Being Scale (WEMWBS) scale, covering both feeling and functioning aspects of mental wellbeing, contains 14 -items with 5 response categories, summed to provide a total score.	Baseline, 2 weeks, 1 month, and 3 months

External Links

•   David Lynch Foundation Website